Tuesday Tidbits

Rx coverage

Tuesday Tidbits

David Ermer–AHRQ, CDC, CMS, Electronic health records, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “President-elect Donald Trump has nominated Dr. Mehmet Oz, a physician, TV personality and former Republican candidate for Senate, to run Medicare and Medicaid as administrator for the CMS.
    • “America is facing a Healthcare Crisis, and there may be no Physician more qualified and capable than Dr. Oz to Make America Healthy Again,” Trump said in his announcement on social media platform Truth Social.
    • “The CMS oversees the healthcare coverage of more than 160 million Americans, or around half the U.S. population, through Medicare, Medicaid, the Children’s Health Insurance Program and Affordable Care Act plans.”
  • Per an HHS press release,
    • “Today, the Surgeon General released a new report on health disparities related to tobacco use, which finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups. Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.
    • “This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.” * * *
    • “For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov
      or www.CDC.gov/EndTobaccoDisparities“
  • FedManager offers its take on the ongoing Federal Employee Benefits Open Season while Serving Those Who Serve delves into Medicare Part D EGWPs participating in the FEHB and PSHB Programs.
  • HealthITBuzz reflects on a “Year of Movement in Pharmacy Interoperabiilty.” The more electronic health record interoperability, the better, after all.
  • The American Hospital Association News tells us,
    • Data released Nov. 18 by the University of Pennsylvania found that 15% of U.S. adults are familiar with the 988 Suicide and Crisis Lifeline, a 1% increase from last year. Those individuals from the survey reported that they knew the number and correctly stated it when asked in an open-ended format. One percent of respondents inaccurately reported the number was 911, an improvement from 4% in 2023. The 988 hotline launched in July 2022.”
    • The FEHBlog wonders if 911 operators transfer appropriate calls to 988 operators.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced a $100,000 civil monetary penalty against Rio Hondo Community Mental Health Center (“Rio Hondo”) in California. The penalty resolves an investigation into Rio Hondo over a failure to provide a patient with timely access to their medical records. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule’s right of access provisions require that individuals or their personal representatives have timely access to their health information (within 30 days, with the possibility of one 30-day extension) and for a reasonable, cost-based fee. OCR enforces the HIPAA Privacy Rule, which establishes national standards to protect individuals’ medical records; sets limits and conditions on the uses and disclosures of protected health information; and gives individuals certain rights, including the right to timely access and to obtain a copy of their health records.” * * *
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/rio-hondo/notice-final-determination/index.html“

From the public health and medical research front,

  • The New York Times reports,
    • “If I drew you a graph that showed the death rate among American kids, you would see a backward check mark: Fewer kids died over the last several decades, thanks to everything from leukemia drugs to bicycle helmets. Then, suddenly, came a reversal.
    • “I first noticed this in 2021 while poking around in mortality data from the virus-ridden year before. It looked bad. I knew that kids who contracted Covid tended to fare better than older people, but was the virus killing them, too?
    • “Nope. It wasn’t the virus. It was injuries — mostly from guns and drugs. From 2019 to 2021, the child death rate rose more steeply than it had in at least half a century. It stayed high after that. Despite all of the medical advances and public health gains, there are enough injuries [from firearms, traffic, drugs and drowning] to have changed the direction of the chart.”
  • Consumer Reports, writing in the Washington Post, informs us about “microplastics, phthalates, BPA and PFAS. We encounter these potentially toxic materials in everyday life. Here’s the difference among them.”
  • BioPharma Dive let us know,
    • “An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday.
    • “The drugmaker plans to discuss data from the trial, which it didn’t disclose in full, with the Food and Drug Administration and other regulators. The intravenous form of Keytruda is expected to lose U.S. patent protection in 2028, which would open the door to biosimilar competitors.
    • “Rival Roche has already gained FDA approval for a subcutaneous version of its competing immunotherapy Tecentriq, while Bristol Myers Squibb is awaiting an FDA decision on an under-the-skin injection of Opdivo. Merck could be as much as a year or more away from approval of subcutaneous Keytruda.”
  • and
    • “An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.
    • “Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks.
    • “Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.”
  • The National Institutes of Health offers information about “Weight-loss surgery in teens | Sugar intake and chronic disease risk | Mapping cancer formation and spread.”
  • Per an NIH press release,
    • “Experts convened by the National Institutes of Health (NIH) have identified five elements of a brain-based condition that has emerged as a leading cause of vision impairment starting in childhood in the United States and other industrialized nations. Known as cerebral (or cortical) visual impairment (CVI), some estimates suggest that at least 3% of primary school children exhibit CVI-related visual problems, which vary, but may include difficulty visually searching for an object or person or understanding a scene involving complex motion. Their report, based on evidence and expert opinion, was published today in Ophthalmology.
    • “Lack of awareness about CVI is a large factor leading to it to be misdiagnosed or undiagnosed, which can mean years of frustration for children and parents who are unaware of an underlying vision issue and don’t receive help for it,” said report co-author, Lotfi B. Merabet, O.D., Ph.D., associate professor of ophthalmology, Massachusetts Eye and Ear and Harvard Medical School, Boston.
    • “Clarifying the factors for suspecting CVI should help build awareness and help eye care providers identify children for further assessment so they can benefit from rehabilitation and accommodation strategies as early as possible,” said report co-author, Melinda Y. Chang, M.D., assistant professor of clinical ophthalmology at the University of Southern California, Los Angeles.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER will assess the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • The assessment will be publicly discussed during a meeting of the CTAF in June 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
  • The U.S. Preventive Services Task Force opened a public comment period of its Grade A recommendation that all pregnant women undergo early screening for syphilis infection. This recommendation confirms an earlier decision made in 2018. The public comment period ends on December 23, 2024.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Rx, CVS Health’s Caremark and Cigna’s Express Scripts have sued the Federal Trade Commission alleging the agency’s in-house case over insulin prices is unconstitutional.
    • “The companies, the three largest pharmacy benefit managers by market share, are suing to block the administrative proceedings, according to a complaint filed Tuesday in the U.S. District Court for the Eastern District of Missouri. The PBMs’ associated group purchasing organizations Emisar Pharma Services, Zinc Health Services and Ascent Health Services, respectively, are also plaintiffs in the case.” * * *
    • “The PBMs allege the FTC’s claims — which they deny — involve private rights that should be heard in a federal court and allege the administrative proceeding violates their due process rights under the Fifth Amendment.”
  • and
    • “Change Healthcare’s vital clearinghouse platform has been restored after a cyberattack on the UnitedHealth Group subsidiary caused unprecedented billing and payment disruptions for providers nationwide, the company announced on its status webpage.
    • “This is a big step for the technology company after its systems were taken offline following a February ransomware attack that caused widespread disruptions throughout the healthcare system. Change Healthcare operates as the largest clearinghouse for billing and payments in the U.S., processing 15 billion transactions annually and managing about one-third of patient records.” 
  • and
    • “CVS Health is the first company to earn a Health Equity Accreditation from URAC.
    • “The independent nonprofit accrediting organization said CVS was the first to apply to the program, which started in 2023.” * * *
    • “CVS’ social determinants of health dashboard — aimed at helping identify individuals who are at risk of poor outcomes and refer them to community-based programs and screening options — contributed to its accreditation, URAC said. The company’s work in addressing health-related cost and access barriers played a role too, according to URAC.”
  • Fierce Healthcare adds,
    • “Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company’s latest leadership shake-up.
    • “CVS announced Tuesday that Sree Chaguturu, M.D., will step into the role of president for healthcare delivery alongside his existing title as chief medical officer. In the announcement, CEO David Joyner said that Pykosz let the company’s top brass know “earlier in the year that he planned to move on from the company and we appreciate him helping to lead a smooth transition.”
    • “As CMO, Chaguturu oversees CVS’ medical affairs organization and is responsible for clinical quality, patient outcomes, addressing access gaps and managing health costs across the enterprise. He was also previously the chief medical officer at CVS’ Caremark pharmacy benefit manager.”
  • Fierce Pharma identifies the 2024’s Fiercest Women in Life Sciences. Kudos to them!
  • KFF brings us up to date on the national IV fluid shortage created by Hurricane Helene.
    • “[H]ospitals are facing seasonal strains on their already limited IV fluid resources, said Sam Elgawly, chief of resource stewardship at Inova, a health system in the Washington, D.C., area.
    • “We’ve been very aggressive in our conservation measures,” Elgawly said, stressing that he does not believe patient care has been compromised. He told KFF Health News that across the system IV fluid usage has dropped 55% since early October.
    • “Elgawly called the shortage a crisis that he expects to have to continue managing for some time. “We are going to operate under the assumption that this is going to be the way it is through the end of 2024 and have adopted our demand/conservation measures accordingly,” he said.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration alerted healthcare providers Friday about the safety and supply of Getinge/Maquet vessel harvesting devices.
    • “The letter to providers describes issues with Getinge/Maquet VasoView Hemopro Endoscopic Vessel Harvesting (EVH) Systems. Getinge recalled the devices in September after receiving 18 complaints about Hemopro 1.5 devices in four months, including reports of 17 serious injuries.
    • “The FDA letter addresses the injury reports and warns the removal of Hemopro 1.5 may interrupt the supply of EVH devices. The devices are now on the FDA’s device shortage list.”

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he would nominate environmental lawyer and vaccine skeptic Robert F. Kennedy Jr. to serve as health and human services secretary, putting a noted critic of U.S. public policy atop the country’s vast health bureaucracy. 
    • “Kennedy has promised sweeping changes to food-and-drug regulation and government-funded scientific research, in recent days saying the Food and Drug Administration’s nutrition department needed to be eliminated and warning the agency’s employees to “pack your bags.”
    • “Kennedy, 70 years old, abandoned his independent presidential bid in August and endorsed Trump, promising that he and the Republican would work to “make America healthy again.”
    • “Kennedy said on social media after his nomination that “we have a generational opportunity to bring together the greatest minds in science, medicine, industry, and government to put an end to the chronic disease epidemic.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a new nationwide campaign to raise public awareness of the National Maternal Mental Health Hotline (1-833-TLC-MAMA). The National Maternal Mental Health Hotline is a cornerstone of the Biden-Harris Administration’s broader efforts to improve maternal health and supports HRSA’s ongoing initiative to reduce maternal mortality and health disparities. While mental health conditions are the leading cause of pregnancy-related deaths, more than 80 percent of pregnancy-related deaths are preventable according to the Centers for Disease Control and Prevention (CDC).
    • “As part of the campaign, HHS will collaborate with companies and organizations such as retailers, grocers, pharmacies, and health and community associations to publicize mental health resources for moms and pregnant women in everyday locations. The first six Maternal Mental Health Champions announced today have thousands of locations and a broad presence in all 50 states, Washington, D.C., Puerto Rico, and the U.S. Virgin Islands. HRSA Deputy Administrator Jordan Grossman announced this campaign in conjunction with HRSA’s latest state Enhancing Maternal Health Initiative convening in Portland, Oregon.” * * *
    • “The National Maternal Mental Health Hotline is a safe space for pregnant women and new moms to get the emotional and mental health support they need, and we want to continue to reach even more pregnant women, new moms, and their loved ones with this vital support,” said HRSA Administrator Carole Johnson. “That’s why we are excited to partner with grocery stores, pharmacies, and other organizations to help get the word out about this important resource for in communities across the country.” * * *
    • “For more information on the National Maternal Mental Health Hotline and to download new promotional materials, visit: https://mchb.hrsa.gov/national-maternal-mental-health-hotline.”
  • Healthcare Dive lets us know,
    • “The Biden administration is moving to lessen the importance of a controversial metric used to calculate valuable Medicare Advantage star ratings that’s been at the center of recent lawsuits.
    • “UnitedHealthcare, Centene and Humana have all sued the government this fall for downgrading their quality scores based on assessments of their customer support centers. Payers argued the measure had an outsized impact on final star ratings, and it now seems regulators might agree.
    • “We have already put in place that [the call center metric] is going to have a smaller weighting on star ratings moving forward,” CMS Medicare Director Meena Seshamani said Wednesday at the Milken Institute’s Future of Health Summit in Washington, D.C.”
  • Federal News Network interviews OPM Director Rob Shriver about the Federal Employee Benefits Open Season.
  • Tammy Flanagan, writing in Govexec, identifies federal and postal employee “retirement decisions that require careful consideration since they cannot be changed.”
  • Federal News Network tells us,
    • “The Postal Service is reporting a deeper financial loss than it’s seen in recent years and is calling on Congress and the incoming Trump administration to address rising costs that are beyond its control.  
    • “USPS reported a $9.5 billion net loss for fiscal 2024, despite year-over-year growth in revenue and a reduction in its controllable expenses. The agency saw a $6.5 billion loss in FY 2023. 
    • “USPS officials said 80% of the agency’s losses come from fixed costs — including pension contributions for its retirees and workers’ compensation claims for employees injured on the job.  
    • “The agency will not seek to raise mail prices in January 2025, but it plans to keep setting higher prices each July and January after that, through the end of 2027.
    • “USPS projections show the agency will end FY 2025 with a $6.9 billion net loss for FY 2025 and is falling short of its “break-even” goal under a 10-year reform plan.” 

From the public health and medical research front,

  • STAT News reports,
    • “A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday.
    • “The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus. But genetic sequencing showed that it is of a genotype that has been found in wild birds, not the version that has been circulating in dairy cattle in the U.S. 
    • “Canada has been doing surveillance in dairy cows looking for the virus, but to date has not detected it in any herds.
    • “Bonnie Henry, British Columbia’s provincial health officer, told STAT in an interview that she’d been expecting these genetic sequencing results. “That’s what we’ve been seeing consistently,” she said.”
  • HCPLive informs us,
    • “Initiation of population-wide screening for chronic kidney disease (CKD) followed by treatment with conventional CKD therapy combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors would be cost-effective for US adults when initiated at 55 years of age, according to findings from a recent study.
    • “Results showed screening every 5 years combined with SGLT2 inhibitors from 55-75 years of age would cost $128,400 per quality-adjusted life year (QALY) gained. While initiation of screening at 35 or 45 years of age produced larger population health benefits, these strategies incurred additional costs totaling> $200,000 per QALY gained.
    • “In the absence of effective CKD treatment options at the time, in 2012, the US Preventive Services Task Force found insufficient evidence to show screening and early detection of CKD improved clinical outcomes. However, the recent emergence of SGLT2 inhibitors as a practice-changing therapy for CKD has prompted clinical guideline organizations to update standard of care recommendations for CKD to include these medications.”
  • Per BioPharma Dive,
    • “PTC Therapeutics on Wednesday won Food and Drug Administration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain.
    • “The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The potentially fatal disorder typically manifests in the first six months after babies are born and affects all aspects of their lives, both physical and mental.
    • “Kebilidi is designed to deliver a functioning DDC gene into the body, correcting the genetic defect that causes the disorder. It’s administered by a neurosurgeon in four infusions in one session.”
  • Healthcare Dive relates,
    • “Increased telehealth utilization wasn’t linked to more low-value services at primary care clinics, according to a study published this week in JAMA Network Open.
    • “The research found no association between practices that used high levels of telehealth and most types of low-value care, or services that have no clinical benefit for patients and rack up costs.
    • “The findings could reassure policymakers who have raised concerns that virtual care could increase unnecessary or wasteful services and drive-up healthcare spending, the study’s authors wrote.” 
  • The Wall Street Journal reports,
    • “Intermittent fasting probably isn’t the health hack you hoped it would be.
    • “More studies suggest the tactic can help you lose weight, but likely isn’t a silver bullet for other health improvements like lowering your inflammation levels or lengthening your lifespan. And some evidence suggests fasting can make it harder to build and retain muscle.
    • “People were hoping it was this magical thing that did amazing things for them,” says Krista Varady, a professor of nutrition at the University of Illinois Chicago who has been studying intermittent fasting for 20 years. “All it does is help people eat less.”

From the U.S. healthcare business front,

  • AHIP lets us know,
    • “With more than half of Americans – approximately 180 million people – receiving health care coverage through work, a new nationwide poll finds that a strong majority are satisfied with their current employer-provided plans (75%) and prefer to get their coverage through an employer rather than through the federal or state government (74%).
    • “The poll found that Americans’ satisfaction with employer-provided coverage is driven by the comprehensive coverage (49%), affordability (48%) and choice of providers (45%) their plans provide.” * * *
    • “The national survey of 1,000 people with employer-provided coverage was conducted online from July 10-19, 2024, with a margin of error of +/- 3%. 
      • “Click here to view the infographic.
      • “Click here to view the survey results.
      • “Click here to view a slide presentation of the survey results.”
  • Fierce Healthcare reports about the second day of its Fierce Health Payer Summit.
  • The FEHBlog took sometime today listening to the HCPLAN Summit, which was held in Baltimore. At the Summit, HCPLAN released the 2024 results of its Alternative Payment Models survey.
  • Adam Fein, writing in his Drug Channels blog, points out,
    • “Uh oh. As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing.
    • “For 2025, DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that the number of PDPs will drop to a historic low. What’s more, the share of plans with a preferred cost sharing pharmacy network will fall to its lowest rate in more than 10 years. Check out the distressing charts below and our review of the remaining national players (Aetna, Cigna, Humana, UnitedHealthcare, and WellCare). 
    • “The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). The IRA makes PDPs less economically viable and will drive even more seniors into Medicare Advantage Prescription Drug (MA-PD) plans—despite the challenges facing those plans. The 2025 decline will occur even after CMS gifted $7 billion to PDPs to prevent a complete collapse of the 2025 market. 
    • “Legislate in haste. Repent in leisure.”
  • STAT News reports,
    • “In a move to safeguard the company’s dominant position in cancer, Merck said Thursday it will license a new cancer drug from LaNova Medicines, a Shanghai-based firm, for $588 million upfront and as much as $2.7 billion in potential milestone payments.
    • “The cancer immunotherapy Keytruda, Merck’s most important product and the best-selling drug in the world with $23 billion in annual sales, is set to lose patent protection and face competition from generic drugmakers as early as 2028, and investors are already fretting about what will happen at Merck when revenues from the medicine begin to decline.”
  • Healthcare Dive lets us know,
    • “A group of health systems, led by Boston-based Mass General Brigham, is hoping to solve that problem. 
    • “On Wednesday, the academic medical center launched the Healthcare AI Challenge Collaborative, which will allow participating clinicians to test the latest AI offerings in simulated clinical settings. Clinicians will pit models against each other in head-to-head competition and produce public rankings of the commercial tools by the end of the year.
    • “Participating health systems say that the chance to directly compare AI products is overdue.”
  • Per Fierce Healthcare,
    • “Blue Cross Blue Shield of Massachusetts members will benefit from an expanded partnership with Maven Clinic, a new doula pilot program and more caregiving support in collaboration with Cleo, the company announced Nov. 13.
    • “Its doula program, called Accompany Doula Care, connects “racially and ethnically diverse” members with a trained doula. The pilot will collect data to assess whether the program is adequately reaching members through the birthing timeline, including prenatal visits, in-person support during childbirth and postpartum visits.
    • “Black women experience higher levels of maternal morbidity, Blue Cross’ health equity report found.
    • “Eligible Blues members will also have access to Maven Clinic’s Menopause and Midlife Health program. This program can be utilized as a buy-up for self-insured accounts, a news release explains.”
  • and
    • “Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men’s hair loss and anti-aging skin care.
    • “The new service builds on Amazon One Medical’s existing Pay-per-visit telehealth service that offers healthcare for more than 30 common conditions.
    • “The new service offers a subscription plan with low, upfront monthly pricing for a clinical visit, treatment plan, and free medication delivery. The service initially focuses on five conditions: anti-aging skin care treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness.
    • “Through this service, Prime members can get anti-aging skin care treatment from $10/month; men’s hair loss solutions from $16/month; ED treatment from $19/month; eyelash growth solutions from $43/month; and treatment for motion sickness from $2/use—using Prime Rx at checkout, the company said in a blog post Thursday.”

Happy Veterans Day!

David Ermer–ACA, CDC, Congress, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Megan Lee on Unsplash

Thanks to all those who served our great country.

From Washington, DC,

  • The Washington Post reports,
    • “With Republicans on the cusp of unified control of Washington, Congress appears primed to extend the deadline for a government shutdown well past President-elect Donald Trump’s inauguration.
    • “Lawmakers are discussing a temporary measure that would fund the government into March, according to two people briefed on the discussions, who spoke on the condition of anonymity because they were not authorized to speak publicly.
    • “That would give the Senate plenty of time to begin confirming Trump’s Cabinet nominees, and the House time to plot out maneuvers on tax legislation, without the threat of an imminent government shutdown. Without new legislation, financing for federal agencies will expire Dec. 20.”
  • Modern Health informs us,
    • “A Centers for Disease Control and Prevention report released Friday shows 7.6% of Americans, or 25.3 million people, lacked health insurance during the time of data collection from April to June. Although the rate represents a 0.4 percentage point increase from the year-ago period, it is consistent with 2023’s full-year uninsured rate — a historic annual low.
    • “More people have health insurance coverage than ever before — and the peace of mind that comes with it,” Health and Human Services Department Secretary Xavier Becerra said in a statement Sunday. “That is all thanks to the Affordable Care Act’s expansion of Medicaid and creation of the Marketplace.”
  • The American Hospital Association News tells us,
    • In comments Nov. 11 to the Centers for Medicare & Services on its Notice of Benefit and Payment Parameters for 2026, the AHA expressed support for navigators and other assistance personnel as CMS explores how to expand their responsibilities. Navigators and non-navigator assistance personnel work with hospitals and health systems to help connect consumers to financial assistance resources. 
    • “Navigators are already trusted community resources for navigating health insurance coverage and would be a great asset in helping to reach patients who are otherwise not accessing available financial assistance,” the AHA wrote. “We also encourage navigators and assisters to expand their enrollment counseling to help patients enroll in plans with affordable deductible and cost-sharing requirements based on the patient’s financial resources.”
  • The FEHBlog wishes he knew the objectives of the PSHB navigators and the level of their success in achieving those objectives.

From the public health and medical research front,

  • The Washington Post lets us know,
    • “About 41 percent of U.S. adults with hypertension are unaware they have it, according to a report from the National Center for Health Statistics. Left untreated, high blood pressure can increase the risk for heart disease and stroke.
    • “The American College of Cardiology defines hypertension as having systolic blood pressure of 130 mm Hg or above, or diastolic blood pressure of 80 mm Hg or above.
    • The NCHS data is drawn from a two-year survey, from August 2021 to August 2023, of the U.S. population. The survey sample “is selected through a complex, multistage design,” the NCHS report says. The survey information was collected in stages, including interviews conducted in subjects’ homes and a standardized health examination in a mobile exam site. An average of up to three blood pressure readings were taken.
    • “In adults over age 18, 48 percent of the survey’s 6,084 subjects were found to have hypertension — 60 percent of whom were aware that they had high blood pressure.” 
  • HR Dive relates,
    • “Women’s use of health benefits can influence workplace outcomes such as attendance, retention and productivity, according to a Nov. 6 report from the Integrated Benefit Institute.
    • “For instance, 89% of employed U.S. women said employer benefits positively influence overall workplace satisfaction, and 85% said benefits play a crucial role in attracting and retaining talent.
    • “In particular, benefit use was associated with fewer missed workdays, with the greatest effects seen from mental health benefits, reproductive health services and maternity care.
  • The American Medical Association points out what doctors wish their patients knew about ultra processed foods.
  • Per Healio
    • “Low-level lead poisoning remains prevalent across the United States and globally, warranting screening and identification of those at highest risk, according to a recently published review.
    • “Such poisonings are especially dangerous in children because of their adverse links to cognitive and behavioral development, the researchers pointed out in The New England Journal of Medicine.“
  • Per MedPage Today
    • “Healthy lifestyle choices in midlife may offset genetic risks for dementia, stroke, and late-life depression.
    • “Brain Care Scores measure modifiable risk factors for age-related brain diseases.
    • “Compared with lower Brain Care Scores, higher scores were tied to reduced risk of brain disease in people with genetic predisposition to such diseases.”

From the U.S. healthcare business front,

  • Beckers Payer Issues lets us know,
    • Cigna directly confirmed that it is not pursuing a merger with Humana. 
    • “The Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close,” the company said in a Nov. 11 news release. 
  • Beckers Hospital Review relates,
    • “Oakland, Calif.-based Kaiser Permanente posted a $608 million operating loss (-2.1% operating margin) in the third quarter of 2024, down from an operating income of $156 million (0.6% operating margin) in the same quarter last year, according to its Nov. 8 financial report.  
    • “Kaiser posted an operating revenue of $29 billion in the three months ended Sept. 30, up from $24.9 billion over the same period in 2023. The system reported operating expenses of $29.6 billion in the third quarter, up from $24.7 billion over the same period last year. 
    • “The system said that it continues to experience “increased medical expenses due to higher-than-expected utilization of services, patient acuity and pharmacy costs.” Kaiser also said that its third-quarter performance also included the “impact of Medicaid and other true-ups of annual contracts that normally occur earlier in the year.”
  • STAT News reports,
    • “AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics.
    • “In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.
    • “While we are disappointed with the results, we are continuing to analyze the data to determine next steps,” Roopal Thakkar, AbbVie’s chief scientific officer, said in a statement.”
  • Per Beckers Payer Issues,
    • “A mobile app offered to individuals covered by Centene’s Medicaid plan in Arizona improved medication adherence, and reduced healthcare visits and costs, according to a study published Oct. 21 in The American Journal of Managed Care.
    • “The study found that using the Wellth app helped Medicaid patients with chronic conditions stick to their medications more consistently and reduced unnecessary healthcare visits, ultimately leading to cost savings. The Wellth app uses financial incentives to encourage people to take their medications as prescribed.
    • “Managed care decision makers should consider these findings when deciding what types of behavioral interventions and supports to offer insurance plan members, particularly those managing chronic conditions, to reduce avoidable healthcare expenses,” the researchers wrote.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Susie Wiles, who led Donald Trump’s presidential run, will become his White House chief of staff when he retakes the presidency next year, the campaign said Thursday, making her the first woman to hold that role in U.S. history. * * *”
    • “Those who have worked with her say she is unflappable behind her trademark mirrored sunglasses, avoids the limelight and is quick to give her team credit for her stack of victories.
    • “Every campaign she’s been involved with, she’s been a calming presence,” longtime Florida lobbyist and Wiles ally Brian Ballard told the Journal. “He saw in her the DNA of a winner.”
  • Federal News Network interviews principal Thiago Glieger, a principal of RMG Advisors about getting organized for the Federal Employee Benefits Open Season, which starts next Monday.
  • The Wall Street Journal reports,
    • “U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves. 
    • “The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn’t work at relieving stuffy noses.
    • “The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and no longer sell them. 
    • “After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them. 
    • “The earliest a potential ban would take effect is 2026.
    • “Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.”
  • Beckers Hospital Review adds,
    • “The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration during general anesthesia or deep sedation, Medscape reported Nov. 6. 
    • “The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) released the 2021–2023 Progress Report – PDF for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report provides a high-level overview of progress on select federal agency programs, policies, research, and other activities during fiscal years 2021–2023.”
    • “The progress report features an at-a-glance table of the status of seven core indicators and seven disparities indicators, which were identified in the national plan as a quantitative approach to measuring progress on STI prevention and care in the United States. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets. Of this latter group, six indicators relate to syphilis, which is the focus of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health, Admiral Rachel Levine, M.D.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 16% of American adults — that’s close to 1 in 6 — now has diabetes, according to the latest data from the U.S. Centers for Disease Control and Prevention.
    • “Increasing age and widening waistlines greatly increase the odds for the disease, which happens when the body doesn’t use insulin properly, resulting in high blood sugar levels. If left unchecked, diabetes can be disabling and even life-threatening.
    • “The vast majority (95%) of diabetes cases are type 2 diabetes, which occurs when the body’s cells no longer respond to insulin as they should. Insulin regulates levels of sugar in the blood. Type 2 diabetes is strongly connected to excessive weight. 
    • “The new data, collected from mid-2021 through mid-2023, found a big rise in diabetes rates since 1999-2000, when 9.7% of adult Americans had the disease.
    • ‘There was a significant gender gap in diabetes rates in 2023: Nearly 1 in 5 men (18%) have the illness, compared to 13.7% of women, according to researchers at the CDC’s National Center for Health Statistics (NCHS).”
  • and
    • “A simple nasal swab might help doctors predict the severity of a person’s COVID infection, a new study suggests.
    • “More than 70% of people with mild or moderate COVID develop certain antibodies in their nasal cavities that are linked to fewer symptoms, better immune response and faster recovery, researchers reported Nov. 6 in the journal Science Translational Medicine. * * *
    • “Researchers are working on a nasal swab test that could be used to predict how bad a person’s COVID infection will prove to be.
    • “Right now, we’re either looking at infection risk before it happens or analyzing the infection course well after recovery,” said researcher Ben Babcock, a doctoral candidate at Emory. “Imagine if we could capture the immune response in real time, right in the clinic. A just-in-time test could give physicians and patients the real-time information they need to make faster, smarter treatment decisions.”
  • STAT News informs us,
    • “For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed?
    • “Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the virus might be spreading. Now, long-awaited results from blood testing conducted by the Centers for Disease Control and Prevention are starting to fill in the picture.
    • “The findings, published Thursday, suggest that a small but not insignificant number of H5N1 infections are going undetected among people who work with dairy cows. Blood samples taken from 115 farm workers in Michigan and Colorado over the summer found evidence of a recent infection in eight individuals — half of whom recalled being ill around the same time the cows were sick. The other half could not recall having any symptoms.
    • “Known as serological surveys, the studies involve fishing out antibodies in the blood — molecules made by the immune system in response to a pathogen’s attack that persist long after an infection is over. Finding them is a signal of past contact with a particular virus and helps scientists understand how widely it has spread. 
    • “While the new results suggest that current public health efforts are missing cases, they do not indicate that the strain of H5N1 associated with the dairy cattle outbreak has gained the ability to spread from person to person.”  
  • NBC News reports,
    • “Brie and camembert that may potentially be contaminated with listeria are being recalled, the latest in a series of food incidents in the U.S. in recent months.
    • “Savencia Cheese USA is recalling select soft ripened cheeses after routine testing found the processing equipment at the company’s Lena, Illinois, manufacturing facility may have been contaminated with the bacteria.
    • “Aldi and Market Basket, a supermarket chain in New England, are among stores that sell the cheeses, but the recalled products only had “limited regional distribution” in the U.S., according to the U.S. Food and Drug Administration. 
    • “The “few retailers” that received them have been informed of the possible contamination and are removing products from shelves, the FDA added.
    • “There are no confirmed reports of anyone getting sick so far, the agency noted.”
  • NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Digestion involves much more than just your stomach. The digestive process that fuels your body begins in your mouth each time you take a bite of food and chew. An enzyme in your saliva, called amylase, then starts to break down complex carbohydrates—or starches found in many fruits, vegetables, and grains—into simpler sugars to give you their sweet flavor followed by a burst of energy.
    • “Amylase is the reason we’re so good at turning starch into calories, but it isn’t the same for everyone. There’s plenty of genetic variation in the number of salivary amylase genes (AMY1) our cells carry and, therefore, in how much of this essential starch-busting enzyme people have. Studies have suggested a link between changes in amylase gene copy numbers over time and both the rise of agriculture and starch-heavy diets. Now a study in Science , supported in part by NIH, suggests that extra copies of AMY1 are not only connected to our ability to effectively digest carbs, but also may be more ancient than previously known, arising even before modern humans split from Neanderthals and long before the advent of farming.” * * *
    • ‘The researchers compared the modern-day amylase genes to publicly available DNA sequences from 68 ancient human samples obtained from preserved remains. This revealed that ancient hunter-gatherers already had six to eight AMY1 copies long before people started growing crops and eating high amounts of starch. In fact, genetic variation underlying the production of this enzyme had already spread across Eurasia as far back as 45,000 years ago. However, the new analyses do show an increase in amylase gene copy numbers in the last 4,000 years, as people took up farming.
    • “The study team went on to uncover evidence that the expansion of amylase genes apparently has a longer history than anyone had suspected. Intriguingly, they found three copies of AMY1 in the DNA of three of six Neanderthals and one Denisovan. Neanderthals and Denisovans are both extinct relatives of early humans. The findings suggest that an extra copy of the amylase gene may have arisen as long as 800,000 years ago. The researchers also described how those first extra AMY1 copies could lead to their continued duplications or deletions to produce the wide variation in amylase gene copy numbers seen among modern humans.
    • “This variation in amylase genes would have afforded our ancestors dietary flexibility, allowing them to adapt as diets changed over time. But these discoveries aren’t only fascinating from an evolutionary or historical point of view. They may also lead to new understandings of genetic differences among people today, with potentially important implications for our metabolisms, nutrition, and health.”
  • The Washington Post reports,
    • “Regular practice of yoga can reduce lower-back pain, improve sleep and lessen reliance on pain medication, according to a study conducted by Cleveland Clinic researchers.
    • “The randomized clinical trial studied 140 Cleveland Clinic employees who had disclosed moderate amounts of pain for at least three months. Participants who engaged in a 12-week virtual yoga program reported feeling less pain and better sleep when compared with those who did not have access to the program.”

From the U.S. healthcare business front,

  • Modern Healthcare lets us know,
    • “Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services.
    • “State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company’s latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year.”
  • The American Hospital Association News relates,
    • “Baxter expects to restart a second IV solutions manufacturing line within the next week, the company announced Nov. 7. Along with the first line that resumed production last week, the two lines comprise approximately 50% of the North Cove, N.C., site’s total pre-Hurricane Helene production of IV solutions and about 85% of one-liter solutions production. Hospitals in clinics most commonly use the one-liter solutions. The earliest the facility could begin shipments is late this month.
    • “The company said they expect their peritoneal dialysis and irrigation solutions lines to be the next to resume production and would begin by early December. Baxter expects all lines to restart by the end of the year but does not have a timeline on when total production will return to pre-hurricane levels. The company also said today that it has evaluated and approved more than 200 allocation exception requests to support the neonatal and pediatric patient needs.
    • “In addition, Baxter announced that a second temporary bridge has been installed at the plant and is in use. The bridge will allow traffic for additional trucks and equipment. The first bridge so far has allowed transport of more than 1,000 truckloads of products, Baxter said. Prior to the hurricane, the plant had manufactured approximately 60% — or 1.5 million bags or 95 truckloads — of IV solution used every day in the U.S.”
  • Beckers Payer Issues ranks the largest payers by 3rd quarter profits.
  • Per Fierce Healthcare,
    • “CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending.
    • “Called Intelligent Specialty Engine, the tool leans on Waltz’s capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor.
    • “The PBM said that the platform is a “unique deployment” of Waltz Health’s Waltz Connect platform, which connects users to a network of both national and regional pharmacies that compete on price. It uses AI to help steer patients to “the most cost-effective and clinically appropriate pharmacies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease.
    • “The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and the “evolving landscape of Duchenne” with the approval of Sarepta’s gene therapy Elevidys all played a role, Chief Scientific Officer Louise Rodino-Klapac told analysts and investors.
    • “Elevidys revenue climbed to $181 million in the third quarter from $122 million in the second quarter, beating analyst estimates of about $160 million. Sarepta also pulled in $9.5 million in royalties from Roche, which sells the gene therapy outside the U.S.“
  • Per Fierce Pharma,
    • “Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir. 
    • “But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
    • “Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
    • “Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.”
  • Per MedTech Dive,
    • “Johnson & Johnson received Food and Drug Administration approvalfor its Varipulse pulsed field ablation (PFA) system, joining Boston Scientific and Medtronic in the U.S. market for the fast-growing atrial fibrillation (AFib) treatment.
    • “Varipulse is approved to treat patients with drug-resistant, recurrent paroxysmal AFib, a common form of abnormal rhythm in the heart’s upper chambers, the company said Thursday. The platform is integrated with J&J’s Carto 3 mapping system in a single device that enables electrophysiologists to view inside the heart to position the catheter. 
    • “We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow,” Jasmina Brooks, president of electrophysiology at J&J Medtech, said in a statement.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • On Wednesday morning, OPM’s supplemental Postal Service Health Benefits Program final rule was posted on the Federal Register’s Public Inspection List. The Federal Register version of the rule is being published on Thursday October 24, a week or so earlier than expected.
  • The final rule maintains OPM’s proposed exclusion of Part D eligible Postal annuitants from their PSHB plan’s prescription drug benefits in the event that they opt out of their Plan’s Part D EGWP benefits. A Part D EGWP integrates the Plan’s benefits with Medicare Part D benefits.
  • A Part D EGWP member subjected to the Part D EGWP penalty continues to pay the full employee / annuitant premium for FEHB coverage.
  • On the brighter side, the final rule does prohibit PSHB plans from auto enrolling Part D eligible annuitants who live overseas because they cannot receive Medicare Part D coverage. OPM also created an opportunity for Postal annuitants to reverse course and join the Part D EGWP if they realize that opting out was a mistake. See 89 Fed. Reg. 85012, 85022.
  • MedPage Today reports,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) on Wednesday endorsed additional doses of COVID vaccine for high-risk groups and recommended lowering the age for adult pneumococcal vaccination from 65 to 50 years.
    • “In an update to recommendations from June in three unanimous votes, ACIP recommended a second dose of the 2024-2025 COVID vaccine for adults ages 65 and older, as well as people ages 6 months to 64 years who are moderately or severely immunocompromised, and additional (three or more) doses for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision making.
    • “The advisors also voted 14-1 to recommend a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults ages 50 and older.
    • “Shortly after the ACIP meeting, CDC Director Mandy Cohen, MD, MPH, endorsed the new COVID vaccine and pneumococcal vaccine recommendations.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus.
    • “The vaccine was previously cleared in adults aged 60 years and older, as well as in pregnant women who are between 32- and 36-weeks’ gestation. With the latest expansion granted by the FDA, Pfizer claims its vaccine now holds the “broadest” indication for adults.
    • “In June, the Centers for Disease Control and Prevention tightened its guidance for RSV vaccination in older adults and delayed making recommendations for adults younger than 60. Advisers to the CDC are set to discuss RSV vaccine data this week but aren’t scheduled to vote on guidance for younger adults.”
  • Healthcare Dive lets us know,
    • “Centene is suing the federal government over its 2025 Medicare Advantage star ratings, the latest in a string of lawsuits from health insurers looking to protect their scores — and the valuable revenue they represent.
    • “The lawsuit filed Tuesday in a Missouri district court accuses the HHS of mishandling a “secret shopper” call meant to assess the quality of Centene’s customer call center, and unfairly including that call in the insurer’s ratings.
    • “Several of Centene’s plans received lower scores as a result, which could cost the insurer $73 million in revenue and cause enrollees to leave the plans — “staggering consequences” from a single call, according to the suit. Centene is requesting the judge order the CMS to recalculate its ratings without including the disputed call.”

From the public health front,

  • NBC News’ Today Show offers updated details on the McDonald’s E. coli outbreak.
  • NBC News reports,
    • Not having — or losing — your sense of smell may be linked to changes in breathing that could lead to depression, social isolation or other mental and physical health problems, a new study suggests. It’s more evidence of how important this often neglected olfactory sense is. 
    • A new analysis of breathing data from 52 volunteers over a 24-hour period revealed that people with a normal sense of smell had little spikes, or “sniffs,” during each breath that were not seen in those with no sense of smell, according to the report published in Nature Communications on Tuesday.” * * *
    • “The main takeaway from the study is better insight into some of the mental issues that some Covid patients who have lost their sense of smell experience, said the study’s lead author, Lior Gorodisky, a Ph.D. candidate in the brain sciences department at the Weizmann Institute of Science in Rehovot, Israel.” * * *   
    • “The little inhalations during a breath, known as the “sniff response,” are something that most of us experience unconsciously every day, Gorodisky said. Those little sniffs tell our brains about good and bad smells. “When you go to a bakery or a flower field, once your brain has sensed the good smell of a pastry or a flower, you immediately take a deeper breath,” Gorodisky said.”
        
  • The National Cancer Institute’s latest Cancer Information Highlights concern “Easing Money Troubles | Cachexia | Nutrition.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a proof-of-concept precision medicine clinical trial to test new treatment combinations targeting specific genetic changes in the cancer cells of people with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial, funded by NIH’s National Cancer Institute (NCI), aims to accelerate the discovery of more tailored treatments for these aggressive cancers of the blood and bone marrow.
    • “NCI is uniquely positioned to conduct this type of study, which is one of a series of NCI precision medicine trials that are helping pave the way for more personalized treatment of cancer,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “By making these trials available to patients in communities around the country, we bring cutting edge science to people where they live and ensure that what we learn from our study participants can benefit patients like them in the future.”  * * *
    • “Learn more about myeloMATCH and the sub-studies that are currently open.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies Healthgrades’ 50 top hospitals for surgical care, by state. 
  • Fierce Healthcare tells us,
    • “Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July.
    • “The systems said the combining would enable them to significantly improve the quality of care available to people living in the rural Midwest. Should the merger complete, the combined health system’s revenue would be about $10 billion.
    • “Sanford is the largest rural health system in the United States, including 45 hospitals, 211 clinics and more than 160 senior living centers. The Sioux Falls, South Dakota-based provider employs 2,900 physicians and advanced practice providers.
    • “Marshfield, meanwhile, has 60 clinics, 11 hospitals and a children’s hospital. It employs more than 1,700 providers, according to the announcement.
    • “Each also operates a health plan, and combined membership would top 425,000, the health systems said. * * *
    • “The deal is expected to close by the end of the year.”
  • Healthcare Dive informs us about “Executives from Amazon, Walgreens, Blue Shield of California and PhRMA [who] weighed in on how to fix the much-scrutinized pharmacy benefit manager model during HLTH 2024.”

Tuesday’s Tidbits

David Ermer–ACA, AHRQ, CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • OMB’s Office of Information and Regulatory Affairs disclosed it has completed its work on OPM’s supplemental Postal Service Health Benefits rule. That rule now should appear in the Federal Register’s public inspection list shortly. The rule by the way is not on today’s list.
  • The International Foundation of Employee Benefit Plans tells us,
    • The Internal Revenue Service (IRS) released annual inflation adjustments for more than 60 tax provisions in Revenue Procedure 2024-40. Many of these adjustments affect employee benefits.
    • For example,
      • Health flexible spending cafeteria plans. For the taxable years beginning in 2025, the dollar limitation for employee salary reductions for contributions to health flexible spending arrangements rises to $3,300, increasing from $3,200 in tax year 2024. For cafeteria plans that permit the carryover of unused amounts, the maximum carryover amount rises to $660, increasing from $640 in tax year 2024.
      • HSA/HDHP changes were announced before the call letter responses were due at the end of May 2024.
  • The Wall Street Journal adds,
    • “The brackets that determine how much Americans pay in taxes each year are moving up by their smallest amount in a few years.
    • “It will take more income to reach each higher tax bracket after the roughly 2.8% inflation adjustment for 2025, the Internal Revenue Service said Tuesday. The annual adjustments are based on formulas tied to inflation.
    • “This year’s adjustments slightly outpace the current inflation rate, which has been cooling. Still, average hourly earnings rose 4% from a year earlier in September, the Labor Department said.”
  • Per an HHS press release,
    • “Today, the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. Thanks to the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap lowers to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.”
    • “To view the full ASPE issue brief, “Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024” visit: https://aspe.hhs.gov/reports/medicare-part-d-oop-cap“
  • KFF offers a data note.
    • “Overall, just under half of individuals with job-based health coverage are enrolled as a dependent on a family member’s plan (47%). The likelihood of enrolling as a dependent decreases with age. Nearly all children (ages 0-17) with employer-sponsored coverage are enrolled as dependents, usually on a parent’s plan. Young adults, particularly those ages 18-25, are more likely to be covered as dependents than adults overall (72% vs. 32%).
    • “The Affordable Care Act (ACA) requires most employer plans allow young adults to remain on a parent’s plan until age 26. Before the ACA, employers typically limited dependent eligibility for young adults to an age less than 26 and often imposed additional eligibility requirements. This provision of the ACA maintains considerable popularity and has been credited with reducing the uninsured rate among young adults. In 2024, 56% or 19.3 million young adults aged 18-25 were covered on an employer-sponsored plan (Figure 1).
    • “As young adults age, a greater share of those with employer coverage transitions from dependent coverage to being policyholders. For instance, while a majority of 18 and 19-year-olds with employer-sponsored coverage are still covered as dependents, the proportion decreases among those aged 24 and 25 (93% vs. 50%) (Figure 2).”
  • Seeking Alpha lets us know,
    • “Sen. Dick Durbin (D-Ill.), chairman of the Senate Judiciary Committee, has sent letters to Pfizer and Eli Lilly regarding the two drug giants’ relationships with telehealth platforms.
    • “Durbin is seeking to find out whether the two pharmaceutical companies are violating federal anti-kickback laws, according to the letters.
    • “Both Pfizer and Lilly this year launched websites for consumers to find out about their medications, as well as links to talk to a physician online that can prescribe them and an online pharmacy to get prescriptions filled. Pfizer’s is called PfizerForAll, while Lilly’s is name LillyDirect.
    • “Durbin, along with Sens. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), argue that these setups are designed to push consumers to particular drugs “and create the potential for inappropriate prescribing that can increase spending for federal health programs.”
    • “Regarding Pfizer’s platform, the senators say the ease of getting meds prescribed “creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication.”
  • It strikes the FEHBlog as strange that these legislators are attacking the drug manufacturers for disintermediating the middlemen.
  • Fierce Pharma reports
    • “With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
    • “But the U.S. Department of Justice (DOJ) has called a foul.
    • “In federal bankruptcy court in Houston, Texas, the U.S. Trustee program—the DoJ’s unit that oversees bankruptcy cases—has filed a motion (PDF) to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.”
  • MedTech Dive lets us know,
    • “The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center, first reported by Stat and confirmed by MedTech Dive.
    • “Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. 
    • “FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the evidence” and work to build collaboration and transparency at the agency, in an email to staff announcing the new director’s appointment viewed by MedTech Dive.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct. 20. These are the first presumed human cases in the state. The individuals experienced mild symptoms and Benton-Franklin Health District officials have forwarded test samples to the Centers for Disease Control and Prevention for final confirmation and analysis. Washington is the sixth state with human H5N1 infection, which has caused outbreaks in poultry, dairy cattle and wildlife. The CDC considers the risk of H5N1 bird flu to the general public to be low.”
  • The New York Times tells us,
    • “New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.
    • “Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.
    • “Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”
    • “The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.”
  • BioPharma Dive reports about “RNA editing: emerging from CRISPR’s shadow. Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.”
    • “RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli Lilly, Roche and Novo Nordisk, have taken an interest.
    • “RNA editing’s proponents say it may be safer and more flexible than DNA editing. Those advantages, they contend, will enable RNA editing to address more diseases, including common conditions that are now beyond genetic medicine’s reach.
    • “It has all the features of a technology that could leapfrog other editing technologies,” said Michael Ehlers, a general partner at Apple Tree Partners and the CEO of RNA editing startup Ascidian Therapeutics.”
  • The U.S. Preventive Services Task Force has opened for public comment its Grade B recommendation that doctors “provide or refer pregnant and postpartum persons to interventions that support breastfeeding.” This is a confirmation of a 2016 Grade B recommendation. The public comment period is open until November 18, 2024.
  • Per Food Navigator
  • The Centers for Disease Control and Prevention issued the following alert today.
    • CDC, FDA, USDA FSIS, and public health officials in multiple states are investigating an outbreak of E. coli O157:H7 infections. Most people in this outbreak are reporting eating the Quarter Pounder hamburger at McDonald’s before becoming sick. It is not yet known which specific food ingredient is contaminated.
    • McDonald’s is collaborating with investigation partners to determine what food ingredient in Quarter Pounders is making people sick [mostly in Colorado and Nebraska]. McDonald’s stopped using fresh slivered onions and quarter pound beef patties in several states while the investigation is ongoing to identify the ingredient causing illness.
  • The Washington Post reports,
    • TreeHouse Foods has expanded an earlier recall of frozen waffles to include all its griddle products, including Belgian waffles and pancakes, over possible listeria contamination.
    • Though no illnesses have been reported, TreeHouse Foods has previously said that the breakfast products were widely distributed throughout the United States and Canada, primarily as private-label offerings by Walmart, Target, Tops, Harris Teeter, Publix and other large merchants.
    • The suspected contamination was discovered through routine testing at a manufacturing facility in Ontario, according to the company announcement.
    • “We are working with our retail customers to retrieve and destroy the recalled products, and encourage consumers to check their freezers for any of the products subject to the recall and dispose of them, or return them to the place of purchase for a refund,” the company said in an unsigned email.

From the U.S. healthcare business front,

  • OptumRx discusses its efforts to “automate prior authorization process for prescription drugs to improve the patient and provider experience.”
  • MedTech Dive brings us up to date on what happened at the MedTech Conference held last week in Canada.

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Office of Personnel Management tells us,
    • “OPM today released the 2024 OPM Federal Employee Viewpoint Survey (FEVS) results, the largest worldwide survey of government employees that annually tracks how employees view workforce management, policies, and new initiatives. This year’s results show steady improvement in nearly all areas and the highest-ever Employee Engagement Index (EEI) score since OPM began tracking the metric in 2010. The EEI assesses the critical aspects of an engaged workforce including perception of leadership, supervisors, and intrinsic work experience.” * * *
    • “For the full collection of data, see the OPM FEVS dashboard. This tool provides the public with a dynamic way to access and visualize governmentwide and agency-size survey results and trends of the past five years. New content in the 2024 dashboard release features inclusion of results by Federal Executive Board region and will enhance each Board’s ability to address specific challenges within their geographical area.   
    • “For more information on OPM FEVS methods, see the OPM FEVS Technical Report.”   
  • Federal News Network adds,
    • Many federal human capital experts have said receiving the results of FEVS each year is only the first step for long-term workforce planning. To actually make improvements for their employees, experts say agency leaders have to then analyze the FEVS results and make adjustments as necessary. Later this fall, the Chief Human Capital Officers (CHCO) Council plans to publish a FEVS “toolkit” including recommendations for how leaders can make changes based on FEVS, as well as strategies for action planning and better communication with employees.”
  • Tammy Flanagan, writing in Govexec, points out ten important facts about Medicare that folks approach age 65 need to know.
  • Federal News Network is offering a Federal Benefits Open Season feature
  • The American Hospital Association News lets us know,
    • “A report released Oct. 17 by the Senate Homeland Security Committee’s investigative subcommittee scrutinizes some of the nation’s largest Medicare Advantage insurers for their use of prior authorization and high rates of denials for certain types of care. The subcommittee sought documents and information from the three largest MA insurance companies — UnitedHealthcare, Humana and CVS — and investigated their practice of “intentionally using prior authorization to boost profits by targeting costly yet critical stays in post-acute care facilities.”  
    • “The report found that between 2019 and 2022, UHC, Humana and CVS denied prior authorization requests for post-acute care at far higher rates than other types of care. In 2022, UHC and CVS denied prior authorization requests for post-acute care at approximately three times higher than the companies’ overall denial rates, while Humana’s prior authorization denial rate for post-acute care was more than 16 times higher than its overall denial rate. The report also found increases in post-acute care service requests subjected to prior authorization and denial rates for long-term acute care hospitals, among other findings.”
  • In the past, such practices were praised as cost containment, a now forgotten policy.
  • Thompson Reuters delves into “HHS FAQs [that] elaborate on HIPAA Administrative Simplification Enforcement and Compliance.”

From the public health and medical research front,

  • The Washington Post reports the latest news about the ongoing massive meat recall over a Listeria concern.
    • The recalled products include about 11,765,285 pounds of ready-to-eat meat and poultry items [prepared by BrucePac] that have been sold at stores across the country, including Walmart, Target, Aldi, Trader Joe’s, Kroger, Publix, Wegmans and more.
    • Initially, the [USDA Food Safety and Inspection Service] FSIS said the recalled goods have the establishment numbers 51205 or P-51205 inside or under the USDA mark of inspection on their labels, but it cautioned later that some recalled products could bear a different number “due to further distribution and processing by other establishments.”
    • The FSIS is encouraging consumers to review a more than 340-page list of labels and products included in the recall. The list has images of labels with 7-Eleven, Amazon Kitchen, Boston Market, Dole, Taylor Farms, Giant Eagle and ReadyMeals branding, among several other name brands.
    • Among the recalled items are chicken-based salad bowls, wraps, sandwiches, burritos and pastas.
    • In an Oct. 15 update, the FSIS said that the recalled foods had been distributed to schools, in addition to restaurants and institutions, but that a school distribution list was not yet available. “These products should be thrown away or returned to the place of purchase,” it said.
  • The NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Proteins are vital to our bodies. They serve as structural building blocks for our tissues and organs and are responsible for their functioning in both health and disease. Genes, like recipes, contain instructions for making proteins. Usually, each essential protein is produced from a single gene. Now, new research shows that some bacteria can actually produce two or more proteins from a single gene by “flipping” underlying stretches of DNA.
    • “While scientists have long known that DNA inversions can occur in bacteria, this study is the first to describe these inversions, or “invertons,” within individual genes. What’s more, the findings, from research supported by NIH and reported in the journal Nature , suggest that this flipping happens more often than scientists suspected.
    • “The findings, from Ami S. Bhatt at Stanford Medical School in Stanford, CA, and her colleagues, may have important implications, not only for bacteria, but also for human health. For example, bacteria’s ability to flip genes and alter proteins on their surfaces may restrict the ability of our immune systems to recognize and effectively respond to infectious microbes. Invertons also likely play roles in how our microbiomes, the communities of microorganisms that live in and on us, develop and change within our bodies. Our microbiomes influence our metabolisms, immune responses, and more. * * *
    • “The researchers now want to investigate the mechanisms causing inversions. They expect that these findings are just the tip of the iceberg for understanding the role of invertons in bacteria’s ability to adapt and thrive. They also suggest that, as we learn more about links between this process in bacteria and human diseases, we might find ways to harness it for improving human health.”
  • The Wall Street Journal reports,
    • “Feel like it takes longer to recover from everything these days—whether it’s an injury or poor sleep? That’s the reality of what time is doing to our bodies.
    • “Researchers call our ability to bounce back from health stress “biological resilience.” Evidence suggests that it declines with age, driven by biological and other factors, including parenting, work stress, changes in exercise habits and menopause.
    • “Often, these stresses pile up from early life and can reach a tipping point in our 30s and 40s. 
    • “There are these moments where the whole system seems to undergo like a vibe shift,” says Dr. Heather Whitson, a geriatrician and clinical investigator who directs the Duke University Aging Center.
    • “These midlife declines in resilience parallel emerging science suggesting that aging itself doesn’t happen in a linear way, doctors and researchers say. A small study out of Stanford that looked at biomolecular shifts in the body found two aging “waves” appear to occur around ages 44 and 60. 
    • “While the Stanford study’s findings are difficult to generalize to the broader adult population, family-medicine doctors report seeing similar age-related changes in their patients. The first shift often happens for patients in their late 30s and early 40s, says Dr. Benjamin Missick, family medicine doctor at Novant Health in North Carolina.”
  • and
    • “Drugs such as Novo Nordisk’s blockbuster Ozempic can cut drug and alcohol abuse by up to 50% according to a new study, adding to mounting evidence that the drugs yield health benefits beyond diabetes and weight loss.
    • “In a study published Thursday in scientific journal Addiction, around 500,000 people with a history of opioid use disorder were analyzed, of which just more than 8,000 were taking either GLP-1 drugs such as Ozempic or the similar GIP class of drugs that Eli Lilly’s Mounjaro belongs to.
    • “GLP-1 drugs work by mimicking a gut hormone to control blood sugar and suppress appetite while GIP medications take a dual-target approach by mimicking both the GLP-1 hormone and a second gut hormone that is believed to enhance the drug’s effectiveness.
    • “The study found that those taking the drugs had a 40% lower rate of opioid overdose compared with those who didn’t.
    • “Similarly, an analysis of more than 5,600 people with a history of alcohol use disorder and who took the drugs showed they had a 50% lower rate of intoxication compared with those who didn’t take them.
    • “Our study… reveals the possibilities of a novel therapeutic pathway in substance use treatment,” the study’s lead researcher Fares Qeadan and co-authors of the research report Ashlie McCunn and Benjamin Tingey said.
  • Per BioPharma Dive,
    • “People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control.
    • “Parkinson’s is hallmarked by unintentional muscle movements like shaking or stiffness — the result of nerve cells progressively breaking down and dying. Two drugs, carbidopa and levodopa, have become mainstay treatments for the motor symptoms associated with the disease. AbbVie’s now-approved Vyalev pairs these medications together, but in a unique way.
    • “Vyalev uses “prodrug” versions of carbidopa and levodopa, meaning their therapeutic effects aren’t felt until they’re metabolized. Additionally, Vyalev is the first and only levodopa-based therapy given as a 24-hour infusion, similar to an insulin pump. That could be particularly useful for people with advanced Parkinson’s, who often have trouble swallowing pills because of their impaired motor function.”
  • HCP Live relates,
    • Low-dose oral food challenges in infants with allergies are safe, with skin symptoms as the most common reaction, and no cases of anaphylaxis reported.
    • The study supports early introduction of allergenic foods to build tolerance, aligning with guidelines for early peanut introduction.
  • Beckers Clinical Research notes,
    • “University of Pennsylvania and Children’s Hospital of Philadelphia researchers have developed the first mRNA Clostridioides difficile vaccine — and it’s shown promising results in animal models.
    • “The mRNA vaccine was found to protect against first-time C. diff infections and relapsing infections, promote clearance of existing C. diff bacteria in the gut and overcome deficits in host immunity to protect animals from infection, according to an Oct. 17 system news release. The study was published in Science and could pave the way for clinical trials.
    • “Researchers used the mRNA-LNP vaccine platform — the same that provided the COVID-19 vaccines — to create the C. diff vaccine.” 

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance Health lowered its profit guidance for 2024 on Thursday as the insurer manages “unprecedented challenges” in its Medicaid business.
    • “The company expects net income per diluted share to be approximately $26.50, down from at least $34.05 it projected last quarter. 
    • “But CEO Gail Boudreaux said the increased costs pressuring its Medicaid segment would alleviate as states updated their payment rates to better match member acuity. “We remain confident in the long-term earnings potential of our diverse businesses as we navigate a dynamic operating environment and unprecedented challenges in the Medicaid business,” she said in a statement.” 
  • Modern Healthcare adds
    • “Elevance Health took a hit on its Medicare Advantage star ratings for 2025 and plans to do something about it, President and CEO Gail Boudreaux told investor analysts Thursday.
    • “The for-profit Blue Cross and Blue Shield licensee is the latest Medicare Advantage insurer to push back on the lower quality scores the Centers for Medicare and Medicaid Services announced last week. UnitedHealthcare parent company UnitedHealth Group already sued the agency and Humana is appealing to CMS before taking other actions.
    • “We have challenged our initial score with CMS and are considering all of our options,” Boudreaux said when announcing the company’s third-quarter financial results.”
  • Fierce Healthcare tells us,
    • “Evernorth has tapped Transcarent to power its Oncology Benefit Services offering, which aims to offer end-to-end support for cancer patients for the course of their care journey.
    • “The companies announced Thursday that the program is built on a digital platform that unites key cancer services across the patients’ medical and pharmacy benefits and connects them to a dedicated care team for personalized support and outreach.
    • “This digital platform makes it easier for employers to offer a “streamlined” experience to workers, according to the announcement. Through it, members can reach dedicated oncology nurse navigators who have an American Cancer Society Leadership in Oncology Navigation (ACS LION) certification, find and schedule appointments with cancer centers of excellence, connect to virtual care or have key drug consultations.
    • “Nurse navigators are also trained to provide support to the patients’ caregivers. They’re able to provide educational materials, assistance in appointment scheduling and answers to key questions.”
  • Beckers Hospital Review points out,
    • “Changing consumer trends and market dynamics are leading to hundreds of pharmacy store closures in the U.S.
    • “Brick-and-mortar locations are losing to mail-order and digital options, according to a J.D. Power study of pharmacy customers. Between 2023 and 2024, overall customer satisfaction in physical drug stores declined 10 points on a 1,000-point scale, and satisfaction scores for mail-order pharmacies increased six points.” 
  • “Deloitte research indicates that by ensuring virtual health offerings prioritize convenience and address consumer preferences, health systems could gain a competitive advantage.”
  • Per MedTech Dive,
    • “CMR Surgical won Food and Drug Administration authorization for its Versius robot with an initial indication for gallbladder removal surgery. CMR will partner with select hospitals as the first part of a multistage strategic plan to introduce the robot in the U.S.
    • “The authorization is the first granted through the FDA’s de novo pathway for a multiport, soft tissue general surgical robot, CMR said in a Monday announcement. The de novo process brings new medical devices to market that may serve as predicates for other 510(k) submissions.
    • “The company announced the milestone less than a week after it named Massimiliano Colella as interim CEO, replacing Supratim Bose, who stepped down for personal reasons after less than two years in the job.” 

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • “A majority of House members urged House leaders to not only reverse a proposed 2.8% cut in the Medicare Physician Fee Schedule (MPFS), but also to pass a law that would avoid such cuts in the future.
    • “Increased instability in the healthcare sector due to looming cost hikes impacts the ability of physicians and clinicians to provide the highest quality of care and threatens patient access to affordable healthcare,” read a bipartisan letter signed by 233 House members and spearheaded by Reps. Mariannette Miller-Meeks, MD (R-Iowa) and Jimmy Panetta (D-Calif.). “In lieu of these harmful cuts, which, absent federal legislation, will take effect on January 1, 2025, Congress must pass a bill providing physicians and other clinicians with a payment update that takes into account the cost of actually delivering care to patients.” The letter, which was dated October 11 and made public on Tuesday, was sent to House Speaker Mike Johnson (R-La.) and House Minority Leader Hakeem Jeffries (D-N.Y.).”
  • KFF issued a report on trends in Medicaid outpatient prescription drug spending. Medicaid drug spending is a bellwether because federal law requires that Medicaid receives best pricing from drug manufacturers.
  • The Wall Street Journal offers advice on navigating the Medicare open enrollment period which began today.

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Baxter International started to import IV fluids last week from two of its international manufacturing facilities to address supply shortages in the U.S. 
    • “In coordination with HHS, the FDA and the Administration for Strategic Preparedness and Response, Baxter said it has activated seven plants globally to increase inventory. Recent FDA authorization permits the temporary importation from five Baxter facilities located in Canada, China, Ireland and the U.K., covering 19 IV solution and dialysis production codes. 
    • “The company is also ramping up production and utilizing air and other transportation methods to expedite delivery, according to an Oct. 14 update from the company.”
  • The Washington Post offers more details on “10 million pounds of meat recalled over listeria concern. BrucePac, which produces precooked meat and poultry items, is recalling some products from retailers including Walmart, Target, Aldi, Trader Joe’s and Kroger.”
  • STAT New shares eleven expert opinions “on why gains in cardiovascular disease are stalling and what we can do about it.”
    • “[T]he consensus of the experts interviewed — including Pinney — is that heart disease is far higher than it should be given the tools we have. This is compounded by a disconnect that has formed in the public’s mind between threat and perception. This year, an American Heart Association survey revealed that just over half of Americans are unaware that heart disease remains the leading cause of death, outstripping cancer. 
    • “Nor are most people aware of the vulnerability of particular groups.  “People don’t know that cardiovascular disease is actually the leading cause of mortality in pregnant or postpartum women,” said Janet Wei, assistant medical director of the Biomedical Imaging Research Institute at Cedars-Sinai Medical Center in Los Angeles.
    • “If current trends continue, the heart association estimates, by 2050 at least 6 in 10 U.S. adults will live and die with cardiovascular disease of some type, reflecting an older population burdened by high blood pressure and obesity, despite what we know about those conditions predicting disease.”
  • The Washington Post reports on “digital twinning” of human body organs.
    • “Doctors can create a “digital twin” of your heart and other organs to reduce guesswork during surgery. The technology may transform health care.
    • “Digital twinning has come of age in medicine during the last several years, moving into models for lungs, livers, brains, joints, eyes, blood vessels and other body parts. A virtual twin of an entire human being is somewhere in the future. The technology is also being used to test new medical devices and even drugs, with computer models powerful enough to predict a new molecule’s impact on organs and cells. It holds the potential to scale back, or even replace, the use of animals in experiments and humans in clinical trials.
    • “The technology “is revolutionary,” said Ellen Kuhl, a Stanford University professor of engineering, who is modeling the way a heart translates electrical impulses into physical pumping. “If you do this right, the models you create generalize to a wide population.”
  • Per NIH press releases,
    • “Alzheimer’s disease may damage the brain in two distinct phases, based on new research funded by the National Institutes of Health (NIH) using sophisticated brain mapping tools. According to researchers who discovered this new view, the first, early phase happens slowly and silently — before people experience memory problems — harming just a few vulnerable cell types. In contrast, the second, late phase causes damage that is more widely destructive and coincides with the appearance of symptoms and the rapid accumulation of plaques, tangles, and other Alzheimer’s hallmarks.
    • “One of the challenges to diagnosing and treating Alzheimer’s is that much of the damage to the brain happens well before symptoms occur. The ability to detect these early changes means that, for the first time, we can see what is happening to a person’s brain during the earliest periods of the disease,” said Richard J. Hodes, M.D., director, NIH National Institute on Aging. “The results fundamentally alter scientists’ understanding of how Alzheimer’s harms the brain and will guide the development of new treatments for this devastating disorder.”
  • and
  • NIH also shares “Research in Context: Can we slow aging?”
  • KFF released an issue brief about “Teens, Drugs, and Overdose: Contrasting Pre-Pandemic and Current Trends.”
    • “This issue brief analyzes CDC WONDER data – including provisional data from 2023 – and data from national surveys of adolescent youth to highlight trends in substance use and overdose deaths. It explores how and where teenagers receive substance use information and treatment and how school settings can be leveraged to enhance prevention measures. Lastly, it examines federal and state prevention efforts and social media’s role in the drug crisis.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “UnitedHealth Group lowered the top end of its adjusted profit guidance for 2024 on Tuesday as the healthcare giant continues to deal with the fallout from a cyberattack on subsidiary Change Healthcare.
    • “The company decreased its adjusted net earnings outlook to $27.50 to $27.75 per share for this year, compared with its previous $27.50 to $28 range. The updated guidance includes $0.75 per share in impacts from the cyberattack on technology firm and claims professor Change, about a $0.10 per share increase from UnitedHealth’s estimate last quarter. 
    • “But the insurer still beat investor expectations on revenue and earnings per share in the third quarter, driven by expansion in people served in UnitedHealthcare and its health services unit Optum.”
  • and
    • “CVS Health is discontinuing certain infusion services offered through its Coram business and also plans to close or sell 29 pharmacies in the coming months, a spokesperson confirmed to Healthcare Dive.
    • “The retail giant stopped accepting new patients for its antibiotics, inotropic medications, total parenteral nutrition and acute home infusion therapies programs last week. Coram will continue to provide infusion services for specialty medications and enteral nutrition. 
    • “CVS Health may conduct layoffs as part of the reduction in services. Impacted employees would be notified in mid-November and terminated in the new year, according to the spokesperson. Any workforce reductions are separate from CVS Health’s announcement last month that it would lay off 2,900 employees.”
  • and
    • “Continuing its belt-tightening, Walgreens will close about 1,200 storesover the next three years, starting with about 500 in the current fiscal year, which just commenced.
    • “That’s more than half the number of stores the drugstore retailer acquired from Rite Aid seven years ago, after they called off their planned merger.
    • “Retail operations were a drag on results: Q4 retail sales fell 3.5% year over year, with comps down 1.7%, while full-year retail sales fell 4.6%, with comps down 3.4%, per an earnings presentation. Beauty, seasonal and general merchandise siphoned about 150 basis points from Q4 comps, and elevated shrink levels offset positive impacts on retail adjusted gross margin from category mix and private labels.”
  • Per BioPharma Dive,
    • “Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third quarter, the pharmaceutical company reported Tuesday, as new approvals helped broaden the two medicines’ market reach.
    • “The growth from Carvykti and Tremfya comes as J&J prepares for biosimilar competition to its second best-selling drug, Stelara, in January 2025. Biosimilars have already arrived in Europe and, alongside larger-than-expected insurer rebates, drove Stelara’s third quarter sales down 7% compared to last year.
    • “While analysts viewed the performance of J&J’s medical device division as underwhelming, J&J was still confident enough in its outlook to raise operational sales guidance for the full year slightly.”
  • Beckers Hospital CFO Report offers 22 statistics on inpatient length of stay.
    • “The average length of stay at hospitals across the U.S. is dropping slightly, while observation days have big declines year over year, according to Kaufman Hall’s National Hospital Flash Report. 
    • “The report includes data from 1,300 hospitals in August, which are tracked monthly for operational and financial trends. The length of stay dropped one to two percentage points on average for most hospitals, regardless of region and size. There was a wider variation in the observation days as a percentage of patient days, as patients are leaving the hospital quicker this year compared to last year.
    • “This development indicates less severe patient acuity and efficient care transition pathways,” the report authors noted.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
  • Govexec observes “The Office of Personnel Management’s inspector general last month reported that the federal government’s dedicated HR agency faces taller tasks in the form of launching a health insurance program for postal workers and verifying enrollees’ eligibility for the Federal Employees Health Benefits Program.”
  • While Govexec accurately reflects the substance of the OIG’s report, the FEHBlog disagrees with the OIG conclusions for the following reasons —
    • The OIG and GAO focus on family member eligibility issues. FEHB carriers, or their underwriters, hold the FEHB Program’s insurance risk. The biggest eligibility issue is that OPM does not use the HIPAA 820 enrollment roster transaction which would allow carriers to electronically reconcile individual enrollees with the premiums. This remains a yawning internal gap for the FEHBP.
    • OPM intelligently is assigning Postal employees and annuitants to their appropriate PSHB plan this month. OPM is electronically notifying carriers about these enrollments and OPM is mailing notices to these folks about their enrollments which can be changed during Open Season. If OPM’s new enrollment system breaks down (see healthcare.gov in 2013), the FEHBlog is certain that OPM has a Plan B for making PSHB enrollment change. In the FEHBlog’s view, OPM’s plan provides a high likelihood that the PSHB will timely launch on January 1, 2025.
  • Sequoia reminds us,
    • “The Centers for Medicare and Medicaid Services (CMS) issued Final Rules on how and when civil monetary penalties may be imposed when Responsible Reporting Entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations.
    • “Under MSP rules, group health plans are required to submit certain information to CMS on plan participants that are dual enrolled in the group health plan and Medicare. By doing so, CMS can better identify when another party should pay primary, thereby avoiding unnecessary claims payment mistakes.
    • “Generally, a group health plan RRE is the insurer for fully insured plans and the third-party administrator (TPA) for self-funded plans. Employers are not likely to be an RRE, or otherwise have direct reporting obligations, unless as plan administrator they both self-fund and self-administer the plan. However, employers will need to provide any required information requested by the RRE (i.e., insurer or TPA) for them to accurately submit the reporting on the employer’s group health plan to CMS.
    • “Penalties against an RRE are up to $1,000 (as adjusted) per instance of noncompliance for each calendar day that a record is late, with a maximum annual penalty of $365,000 per instance. Penalties may be waived if RREs can show “good faith efforts” to report any records identified by CMS as being noncompliant. Also, CMS will apply a five-year statute of limitations on assessing civil monetary penalties for violations of mandatory reporting requirements.”
    • Important Dates
      • December 11, 2023: Effective date for the Final Rules.
      • October 11, 2024 / TODAY: Earliest date the provisions of the Final Rules will be applied.
      • October 11, 2025: Start date for compliance review and penalty enforcement.
      • April 1, 2026: CMS begins quarterly compliance audit; reviewing a random sample of 250 new records per quarter for a total of 1,000 records per year.
  • Bloomberg lets us know,
    • “Medicare patients changed to outpatient “observation status” after they were initially hospitalized now have a chance to appeal their reclassification under a rule finalized by the Biden administration on Friday. 
    • “The rule (RIN 0938-AV16) would implement a 2020 ruling by the US District Court for the District of Connecticut in a class action involving a dispute over Medicare’s obligation to pay for hospitalizations and long-term care for elderly patients.”
  • The Wall Street Journal reports,
    • “Teva Pharmaceuticals will pay $450 million to resolve allegations that the generic drug manufacturer submitted false claims and violated a federal law that prohibits the payment of kickbacks to generate federal healthcare business or induce patient referrals.
    • “The Justice Department on Thursday said the settlement amount was based on the company’s, whose U.S. headquarters is in Parsippany, N.J., ability to pay. As part of the settlement, there was no admission of wrongdoing on Teva’s part.
    • ‘Teva said it is pleased to put these matters in the past in order to focus on developing and providing access to medicines for patients who need them.”
  • The American Hospital Association News points out,
    • A survey released Oct. 9 and funded by the American Foundation for Suicide Prevention, the Suicide Prevention Resource Center and the National Action Alliance for Suicide Prevention, a public-private partnership whose members include the AHA, shows 63% of U.S. adults are aware of the 988 Suicide and Crisis Lifeline, a 6% increase from 2022. The survey also found that 71% of adults feel comfortable contacting a mental health hotline, while 15% said they have used one previously. Among other findings, 91% of U.S. adults perceive mental health as equal to or more important than physical health, but 49% feel that physical health is treated as more important.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Seasonal influenza is low nationally. Signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
      • “The new XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly in young children.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory viruses have started for the 2024-25 fall and winter virus season. RSV, influenza, and COVID-19 vaccines are available to provide protection.
  • The University of Minnesota’s CIDRAP tells us,
    • “The California Department of Public Health (CDPH) reported today that the US Centers for Disease Control and Prevention (CDC) has confirmed two of its latest probable H5 avian flu cases, as it reported another likely case based on state testing, which if confirmed would raise the state’s total to seven.
    • “California’s flurry of human cases is occurring amid an ongoing surge of outbreaks affecting the state’s dairy farms, which are concentrated in the Central Valley. Also today, the CDC shared the latest findings from genetic sequencing, which so far show no worrying changes.”
  • and
    • “Genetic sequencing has identified a second cluster of tecovirimat-resistant mpox infections in the United States—the first of its kind involving interstate spread. Researchers from the US Centers for Disease Control and Prevention (CDC) and partners from five affected states reported their findings yesterday in Morbidity and Mortality Weekly Report.
    • “The first Tpoxx-resistant cluster was identified in California in late 2022 and early 2023 in people who hadn’t previously been treated with the drug. The new report describes a new unrelated cluster among 18 people with no previous treatment across multiple states. * * *
    • “In vitro testing of seven samples showed resistance to Tpoxx. Whole-genome sequencing showed that the resistance mutations came from a common ancestor but were distinct from the earlier California cluster.
    • “Researchers said because not all viruses from mpox cases are sequenced, the findings likely underestimate the prevalence of the newly identified drug-resistant variant. They added that more surveillance is needed, as well as adherence to CDC Tpoxx use protocols. Also, they wrote that the findings underscore the need for more treatments for mpox, along with smallpox biothreat preparedness.”
  • Reuters reports,
    • “Roughly 15.5 million U.S. adults have attention-deficit hyperactivity disorder, and most of them struggle with gaining access to treatment for the condition, according to data from a U.S. study released on Thursday.
    • “Only about one-third of those reporting a diagnosis of ADHD said they had received a prescription for a stimulant drug used to treat it in the previous year, researchers reported in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “In addition, nearly three quarters of those with a prescription for a stimulant drug reported difficulty getting it filled because the medication was unavailable.
    • “Worldwide, around 2% to 5% of adults experience ADHD symptoms such as inattention, hyperactivity, and impulsivity. This study provides the first prevalence data on ADHD in U.S. adults since 2003.”
  • The Wall Street Journal informs us,
    • “The Food and Drug Administration approved Pfizer’s Hympavzi to prevent or reduce bleeding episodes in patients with certain kinds of hemophilia, the pharmaceutical company said.
    • “The approval is for patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors, Pfizer said Friday.
    • “Hympavzi, also known as marstacimab, can be given subcutaneously every week for routine prophylaxis in patients aged 12 and up as an alternative to intravenous infusions that are often administered multiple times a week, Pfizer said.
    • “The FDA said the drug is the first non-factor and once-weekly treatment for hemophilia B. The agency said the approval provides “a new treatment option that is the first of its kind to work by targeting a protein in the blood clotting process.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Thursday approved a new Roche drug for breast cancer. Called Itovebi, the drug has been cleared for use with Pfizer’s Ibrance and endocrine therapy in people whose HR-positive, HER2-negative breast tumors have a mutation called PIK3CA.
    • It’ll compete for market share with Novartis’ Piqray, another medicine targeting PIK3CA mutations. Itovebi is one of five drugs Roche aims to add to its portfolio of breast cancer treatments, which already includes the targeted therapies Herceptin, Perjeta and Kadcyla. 
  • Per Health Day,
    • “It’s never too late for a person to quit smoking, even if they’re elderly, a new study finds.
    • “Dropping the smokes even as late as 75 can meaningfully increase a person’s life expectancy, researchers reported recently in the American Journal of Preventive Medicine.
    • “Seniors aged 75 will lose on average more than four years of life if they keep smoking, compared to people who never smoked, researchers found.
    • “On the other hand, a 75-year-old smoker who quits has a 14% chance of gaining at least one extra year of life, and a 65-year-old smoker a 23% chance.
    • “And about 8% of those who quit at age 75 gain at least four years of life compared to those who keep smoking, researchers found.
    • “Quitting smoking is the single best thing anyone at any age can do to increase their life expectancy, researchers concluded.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Fresenius Medical Care said Thursday it will increase its production of IV fluid and peritoneal dialysis (PD) products as the U.S. manages shortages due to Hurricane Helene’s effect on the supply chain.
    • “The company is maximizing production capacity at its international sites to help add supply amid an industrywide supply shortage of PD products and IV fluids, according to the update. Fresenius Medical Care is also exploring other options to address the shortage at the Department of Health and Human Services’ request.”
  • Beckers Payer Issues offer new payer game plans for improving women’s health.
  • Fierce Healthcare provides details on the latest Medicare Advantage star scores.
  • Modern Healthcare notes,
    • “Mary Beth Jenkins will become the president and CEO of University of Pittsburgh Medical Center Health Plan starting Jan. 1. 
    • “Jenkins was also named president of UPMC Insurance Services Division and an executive vice president of the system. She will succeed Diane Holder, who plans to retire Dec. 31 after 40 years with UPMC.
    • “Jenkins has been executive vice president of UPMC Insurance Services Division and chief operating officer of UPMC Health Plan since 2023. She joined Pittsburgh-based UPMC in 1998.” 
  • Optum offers HSA plans tips on personalized member communications strategies.

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

In hurricane news,

  • The New York Times reports,
    • “The Daytona Beach plant that makes nearly a quarter of the IV fluids used in the United States is intact in the wake of Hurricane Milton’s tear across Florida, according to a company spokeswoman.
    • “The site, operated by B Braun Medical, gained prominence this week as a backup source for IV solutions because Hurricane Helene had flooded a major producer of the fluids in North Carolina and left hospitals from California to Virginia with diminishing supplies.
    • “Company workers and officials from the federal Administration for Strategic Preparedness and Response took pre-emptive measures before Milton arrived, loading trucks full of finished IV medical products to ship them out of the storm’s reach through the night Tuesday. 
    • “Allison Longenhagen, a company spokeswoman, said on Thursday that the manufacturing and distribution site at Daytona Beach was intact, and would reopen on Friday.”
  • Healthcare Dive adds,
    • Hurricane Milton hit Florida’s West Coast hard Wednesday night as a Category 3 storm, bringing torrents of rain and tornadoes that caused millions to lose power and triggered widespread destruction to roads and water and sewage services.
    • While the region’s hospitals were largely ready for storm due to legacy hurricane preparations, health systems are still grappling with critical infrastructure outages and are making “hour-by-hour” calculations on whether to evacuate more patients, according to Mary Mayhew, CEO and president of the Florida Hospital Association.
  • Per MedTech Dive,
    • “Baxter said Wednesday it would increase allocation levels of certain IV fluids as the U.S. manages supply shortages after the company’s largest manufacturing plant was damaged by Hurricane Helene.
    • “The company increased allocation levels of its “highest demand” IV fluids from 40% to 60% for direct customers and from 10% to 60% for distributors, effective Wednesday, according to the update. Baxter also increased the allocation level of IV solutions and nutrition products for designated children’s hospitals to 100%.
    • “Baxter said its goal is to restart production at the North Carolina facility in phases and “return to 90% to 100% allocation of certain IV solution product codes by the end of 2024.”

From Washington, DC,

  • Fierce Healthcare lets us know,
    • “Just 40% of Medicare Advantage prescription drug plans offered in 2025 achieved a score of four stars or higher, the Centers for Medicare & Medicaid Services (CMS) revealed Oct. 10.
    • “It is the third consecutive year the portion of MA plans offering four-star plans or greater decreased, with 68% of plans meeting the threshold in 2022. Last year 42% of plans achieved at least a four-star rating.
    • “Weighted by enrollment, 62% of enrollees are currently in contracts with a four-star rating or better. In 2022, 90% of enrollees were in at least a four-star plan.
    • “These star ratings impact the 2026-year quality bonus payments, which has significant financial repercussions to MA plans. They are rated on 40 measures in Medicare Advantage Prescription Drug (MA-PD) plans, 30 measures for MA plans and only 12 measures in solely prescription drug plans.
  • Federal News Network tells us,
    • “The final piece of the puzzle fell into place Thursday morning for calculating the 2025 cost-of-living adjustment (COLA) for Social Security and federal retirement benefits.
    • “Starting in January, many federal retirees will see a 2025 COLA of 2.5% added to their Social Security benefits and federal retirement annuities — but not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, though the exact difference depends on how big the COLA is in a given year:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • For 2025, based on those specifications, FERS retirees will receive a “diet” 2025 COLA of 2% for their retirement benefits beginning in January.
  • Tammy Flanagan, writing in Govexec, provides “a checklist to help [federal and postal employees and retirees] prioritize as [they] sort through your federal retirement and insurance benefits.”
  • Modern Healthcare reports,
    • “Healthcare companies pursuing mergers and acquisitions will be required to submit additional information about their proposals under a final rule approved by the Federal Trade Commission Thursday.
    • “The final rule amends the Hart-Scott-Rodino Act form, which had not been updated for 46 years. When the rule goes into effect, likely early next year, healthcare companies involved in M&A proposals must list acquisitions that occurred within the last five years, disclose private equity and minority stakeholders with decision-making authority and report supplier relationships shared by the merging parties to the FTC, among other requirements.”
  • Bloomberg informs us,
    • Johnson & Johnson did not wrongly manipulate bankruptcy rules when it filed an insolvency case in Texas and not its home state of New Jersey, a federal judge ruled, increasing the odds the consumer health giant can settle claims its baby powder gave women cancer.
    • Judge Christopher Lopez said Thursday he’ll keep a J&J subsidiary in his Houston courtroom, dismissing claims the company improperly skirted a federal appeals court for New Jersey that has twice stopped its bid to end thousands of talc injury lawsuits. 
    • “I want to assure everyone that they are going to get a fair trial in front of me,” Lopez said.
    • J&J is offering more than $8 billion to settle the litigation, a proposal the company has said is supported by roughly 83% of the women who voted on it. The settlement is being offered through a corporate shell J&J created to absorb the cancer claims and file bankruptcy, a controversial legal tactic known as the Texas Two Step.
  • The American Hospital Association News points out,
    • “The Health Resources and Services Administration Oct. 9 announced it will award nearly $19 million to 15 states for identifying and implementing maternal health strategies. The funds are part of HRSA’s Enhancing Maternal Health Initiative and will support State Maternal Health Innovation programs to help identify key drivers of maternal mortality in each state, develop strategies and implement new interventions to address those issues. The state programs have implemented a range of interventions to address maternal health challenges, which include early identification and treatment of hypertension to reduce preeclampsia and other risks, providing mobile simulation trainings to prepare health care providers for a range of adverse labor events, expanding access to trainings to rural and frontier hospitals that do not have a dedicated obstetrics department, and creating resources to improve first responders’ ability to respond to patients with substance use disorder during and after pregnancy.”

From the public health and medical research front,

  • The International Foundation of Employee Benefit Plans lets us know,
    • “Today is World Mental Health Day, a time to recognize the importance of mental health and to reaffirm commitments to improving mental health through education, awareness and advocacy. Many plan sponsors look toward mental health trends to stay informed on strategies for their workforce. Read on for key takeaways from a recent International Foundation webcast on 2024 mental health trends.
    • “The after-effects of the COVID-19 pandemic have resulted in increases in mental health needs across North America. In a 2024 survey from Gallup, U.S. adults reported how they thought mental health issues are handled compared to physical health issues: 38% reported “much worse,” 37% reported “somewhat worse,” and 15% reported “about the same.” The same survey indicates a perception that mental health conditions, including depression and anxiety, have increased over the past five years.
    • “According to a report from SunLife Canada, employers are seeing a rise in mental health care costs, including short- and long-term disability claims. The increased costs are sparking conversations about mental health treatment and leading employers to improve their employee benefits offerings to address mental health care.”
  • Per a U.S. Department of Agriculture press release,
    • BrucePac, a Durant, Okla. establishment, is recalling approximately 9,986,245 pounds of ready-to-eat (RTE) meat and poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    • The ready-to-eat meat and poultry items were produced from June 19, 2024, to October 8, 2024. These products were shipped to other establishments and distributors nationwide then distributed to restaurants and institutions. Information regarding product labels and the list of products will be provided when available.
    • The products subject to recall bear establishment numbers “51205 or P-51205” inside or under the USDA mark of inspection.
  • The American Hospital Association News notes,
    • “The National Institutes of Health Oct. 10 released results of a study that found that infection from COVID-19 in the first wave of the pandemic appeared to significantly increase the risk of heart attack, stroke and death for up to three years for unvaccinated individuals. When infected, those individuals had double the risk for cardiovascular events, and people with severe cases had nearly four times the risk. The study also is the first to show that increased risk of heart attack and stroke in people with severe COVID-19 may have a genetic component involving blood type. It is unclear if the risk of cardiovascular disease is or may be persistent for people who have had severe COVID-19 from 2021 to the present, NIH said.”
  • The Wall Street Journal reports,
    • “Researchers are making progress toward vaccines that train healthy people’s immune systems to eliminate signs of cancer before it develops. 
    • “Vaccines are in early trials for people with inherited genetic mutations that put them at a greater risk. Other shots are designed to destroy precancerous lesions to stop full-blown disease. 
    • “It’s the future of cancer prevention,” says Dr. Ajay Bansal, a gastroenterologist at the University of Kansas Cancer Center.” * * *
    • “Many consider cancer vaccines to be a form of immunotherapy, a kind of treatment that has revolutionized cancer care by using the immune system to beat back cancer cells. Some of those therapies release the brakes on the immune system. Cancer vaccines, by contrast, are meant to boost the immune response and direct it where to go.
    • “Cancer cells and even pre-cancer cells know how to hide from the immune system,” says Dr. Neeha Zaidi, a medical oncologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. “It needs that help from a vaccine.”
  • The National Institutes of Health’s Director, writing her in blog, tells us,
    • “Developing a new drug from scratch can take a decade or more. But sometimes promising treatment options come from repurposing existing drugs for completely different medical conditions. I’m happy to share a new example of this: a cancer drug called pomalidomide that was found in a clinical trial to be safe and effective for treating a blood disorder called hereditary hemorrhagic telangiectasia (HHT).
    • “HHT is an inherited blood vessel disorder that can cause excessive or even life-threatening bleeding. The disease is rare, affecting about 1 in every 5,000 people worldwide, but because HHT is poorly understood and often misdiagnosed, its true incidence is likely greater. Most people with HHT experience recurrent severe nosebleeds, often in combination with mental health disorders such as depression and post-traumatic stress disorder, as well as other health conditions. HHT can also worsen with age and impact quality of life.
    • “However, recent findings from an NIH-supported clinical trial, reported in the New England Journal of Medicine, show that daily treatment with pomalidomide in people with HHT led to a significant reduction in nosebleed severity. Compared to trial participants taking a placebo, those taking pomalidomide needed fewer blood or iron transfusions and reported improvements in their quality of life. Because of these results, the trial was stopped months ahead of schedule, having found sufficient evidence that the treatment was safe and effective.”
  • Per MedPage Today,
    • “Medicare annual wellness visits were associated with a 21% increase in mild cognitive impairment diagnoses.
    • “Those with a wellness evaluation received a diagnosis 76 days earlier than others.
    • “Findings suggest the Medicare wellness visit policy may help identify cognitive impairment earlier.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is moving ahead with expansion plans for Oak Street Health, even as the company reportedly considers a restructuring in the coming months.
    • “CVS is conducting a strategic review, according to media reports citing people familiar with the matter and is weighing options for separating some of the company’s businesses, which include its retail pharmacy, insurance arm Aetna, pharmacy benefit manager CVS Caremark and primary care provider Oak Street.
    • “A spokesperson said CVS is sticking with its previously announced expansion plan for Oak Street but did not respond to questions about how many clinics it has opened this year. As of August, Oak Street had opened 16 clinics in 10 states since December, with aggressive plans to open another 38 or so clinics by the end of the year.”
  • Per Fierce Healthcare,
    • “Henry Ford Health has launched a population health subsidiary to help manage high-risk patients’ conditions and reduce costs tied to preventable hospitalizations or readmissions.
      Troy, Michigan-based Populance is described by the nonprofit health system as an extension of the “dozens” of case management programs it and its insurance subsidiary, Health Alliance Plan, have designed over the past two decades.
    • “Those programs—often designed with value-based care strategies in mind—will be supported at Populance with health analytics capabilities to help spot and address high-risk patients, the system said.
    • “Because we know this approach to population health management works—for our patients, our members and our physicians—we want to make these services available to other physicians, health systems and health plans to create healthier, more equitable outcomes in all the communities we serve,” Robin Damschroder, president of value-based enterprise and chief financial officer at Henry Ford Health, said in a release.”
  • RAND issued a paper titled “The Expense of Heath Care Explained: What Americans Need to Know.”
    • “Health care costs remain a critical concern for policymakers, providers, and patients alike. As voters head to the polls, the effectiveness of recent policies like the No Surprises Act and Medicare drug price negotiations are just beginning to be felt. Meanwhile, other major concerns loom, including how to deal with massive consolidation across the health care industry, and the complex dynamics of drug pricing, as well as burnout and other forces leading to shortages of health care providers.
    • “We asked three experts on the economics of health care to explain some of the financial and public policy forces at work. Cheryl Damberg holds the distinguished chair in Health Care Payment Policy and is director of the RAND Center of Excellence on Health System Performance. Andrew Mulcahy is a senior health economist at RAND who focuses on payments for health care services and prescription drugs. Erin Taylor is a senior policy researcher at RAND who is currently co-project director of the evaluation of the Medicare Part D Senior Savings Model.”
  • Per BioPharma Dive,
    • Within the pharmaceutical industry, a multibillion-dollar race is underway to top Novo Nordisk’s and Eli Lilly’s in-demand obesity drugs.
    • Dozens of companies, large and small, have set out to test experimental medicines they claim could be more potent, convenient or have fewer side effects than Novo’s Wegovy and Lilly’s Zepbound. But those two companies are already hard at work with successors of their own.
    • The next six months figure to be an important preview. Data are expected for a number of drugs that are already, or are shaping up to be, contenders in this high-stakes competition. The readouts will be closely watched, as they will set expectations for how the obesity drug market — currently a duopoly between Lilly and Novo — will look in the future.
  • The article tells you what to expect.
  • The Washington Post reports,
    • “Amazon plans to expand its drug delivery business as the company seeks more ways to insinuate itself into the daily lives of everyday Americans. The move would see the largest online retailer in the United States compete more directly with pharmacy retailers like CVS and Walgreens.
    • “Next year, Amazon customers in 20 cities — including Dallas, Minneapolis and Philadelphia — will be able to get Amazon Pharmacy medications delivered by the company, Amazon Pharmacy VP Hannah McClellan Richards said Wednesday. And a growing number of those deliveries will be completed within less than 24 hours, the company said.
    • “Richards said Amazon will double the number of cities with same-day delivery of medications next year, in part by building pharmacies in existing same-day delivery facilities that are “integrated directly into Amazon’s core logistics network.”